MAUDE Adverse Event Report: MEDINOL LTD. ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number 3X24

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Dyspnea (1816); Ischemia (1942); Stenosis (2263)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

As the report include information on two (2) sizes of the elunir product and since each mdr present only one (1) product, this report is related to one (1) out of two (2) elunir's products, involved in this event.Mfr report # for the other product: 3003084171-2020-00011.The event became known as part of the protocol binding routine periodic follow-up for patients participating in (b)(6) clinical study.

Event Description

On oct.01, 2020 the following complaint received at medinol: on (b)(6) 2020, 146 days following the index procedure the subject started complaining of shortness of breath with just a few steps.On an unspecified date in (b)(6) 2020 the subject underwent a non-diagnostic electrocardiography due to lbbb pattern with maximum 85% pulse achieved with impressive and fast fatigue.A thallium stress test was performed that demonstrated small to mild lateral ischemia consistent with cx or marginal branch, severe ischemia of small to middle size in lad.An echo also demonstrated global function and normal area, 65% ef, no valvular disorder, mild blockage in the outer of the left ventricle by corda, considered an insignificant finding to explain his complaints.The subject was then referred for elective catheterization due to resumption of exertional chest pain and shortness of breath.On (b)(6) 2020, the subject underwent a cardiac catheterization which demonstrated a three-vessel disease.Left main - stenotic 15%; lad mid - patent stent; lad mid to distal - stenotic distal stent edge 95% (>5mm from the stent); 1st diagonal, ostial - stenotic (across stent) 90%; circumflex - irregular and calcified; 1st marginal, proximal to mid-stenotic, calcified, long lesion 90%; 2nd marginal, mid - stenotic calcified 20%; lad/d2 plus rca (not discernable) pci (not discernable) ; rca ostial-stenotic, calcified, damped press 90%.Following the angiography, the subject underwent pci and drug eluting stent to the mid-to-distal lad (95% to 0% final diameter stenosis); pci and des to ostial to proximal rca (90% to unspecified % final diameter stenosis); pci (balloon) to ostial to proximal 2nd diagonal (90% to 0% final diameter stenosis).No dissection was observed during the revascularization procedure.The severe stenosis in om1 was left untreated since the subject had remained asymptomatic from the previous catheterization.He will be treated conservatively but will be evaluated for repeat intervention if his symptoms continue.The subject recovered from the event of unstable angina on (b)(6) 2020 and was discharged home to resume on eliquis, plavix and lipitor.The investigator considered the event of unstable angina not serious, moderate in severity and not related to the device or procedure initial baim safety medical assessment: unstable angina possibly related to device/procedure, not unanticipated based on known risks, referred to cec for endpoint adjudication.Atp (b)(6) 2020.Following to cec meeting held on (b)(6) 2020 it was decided by the cec members that the event is possible related to device and procedure.

Manufacturer Narrative

Angiogram analysis (dated october 29, 2020) indicated the following: 1.Ostial lesion of a dominant rca is noted.2.Tight lesion of a small m1.3.The lad is very calcified with a hazy tight lesion at the bifurcation of d2, which is small artery.4.The lesion appears to be at the distal end of the stent in the mid-lad 5.Ostial lesion of d.1 6.Wiring of lad and d2 is done.7.Pre-dilation of lad and d2.8.A 3rd stent is implanted in the mid-lad with a good angiographic result in the lad.9.Flow in d2 is compromised.10.Kbt of lad and d2 is performed, the flow in d2 and lad is timi3.11.Pci to the ostial lesion of the rca is done.12.A stent is implanted in the ostial rca with a good angiographic result in my expert opinion: the event is possibly related to the stent.According to the angiogram analysis, medinol was able to attribute of the event to a single device (lot#: lnrin00362) detailed in the this report.The second device, detailed under mfr report#: 3003084171-2020-00011, was not related to the current complaint.Dhr (device history records) review (dated november 16, 2020) indicated that the product was supplied meeting specifications.Ifu (instructions for use) review (dated november 16, 2020) indicated that no deviation of ifu was reported.Overall conclusions from final report (dated november 23, 2020).1.The review of the dhr (device history record) indicates that the product was supplied meeting specifications.2.Out of the two lots involved in the index procedure, the investigation was able to attribute the event to a single device catalogue#: lun300r24in01, type 3.0 x 24mm, from lot #: lnrin00362.3.Angina is well-known potential adverse event that may be associated with the implantation of a coronary stent in coronary arteries and is listed as such in section 7 of the elunir ifu.In this case the event was not unanticipated based on the known risks, including the patient's long history of coronary disease.4.The investigation findings do not lead to a clear conclusion about the root cause of the reported adverse event.Stenosis was observed at a number of locations, only one of them at the site of the elunir stent, and it is not clear which of them caused the angina.5.The event of this complaint is addressed in the elunir dmfea report and the risk remains low.No new risks were identified.6.The patient recovered after treatment of the stenoses with two stents and pci.

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, jerusalem 97775 08; IS 9777508
• MDR Report Key: 10747680
• MDR Text Key: 213440101
• Report Number: 3003084171-2020-00010
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P170008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: 3X24
• Device Catalogue Number: LUN300R24IN
• Device Lot Number: LNRIN00362
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR